Cognitive Training Video Game to Target Subclinical Depressive Symptoms in Youth

NCT05697627 | Completed Results FDA Device

• 1 other identifier: HUM00227345
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine how cognitive control training (CCT) changes behavior in youth with subclinical depressive symptoms. This research will show what types of behavior changes are important for CCT to help reduce depressive symptoms. In the future, this information will be used to try to improve prevention of the development of depression, so that it can help more patients.

Conditions

Depression; Subclinical Depressive Symptoms

Keywords

Cognitive Training Video Game

Outcome Measures

Primary Outcomes (6)

• Change in Depressive Symptoms as Measured by Children's Depression Inventory (CDI)

  The CDI was a self-report, 27 item scale used to measure depressive symptoms. Total scores on the CDI ranged from 0 (no depressive symptoms) to 54 (extremely severe depressive symptoms). Higher scores indicated worse depressive symptoms. CDI scores were collected from participants at three timepoints: 1) baseline, 2) approximately 5 weeks after baseline, and 3) up to 4 months after baseline. Results reflect CDI scores collected at the first and second timepoints.

  Baseline and approximately 5 weeks after

• Change in Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R)

  The CDRS-R is a clinician-administered tool used to assess the severity of depression in children and adolescents based on a 17-item scale of depressive symptoms. Total raw scores on this scale range from 17-113, with 17 indicating no or minimal depressive symptoms and 113 indicating extremely severe symptoms of depression. CDRS-R scores were collected from participants at three timepoints: 1) baseline, 2) approximately 5 weeks after baseline, and 3) up to 4 months after baseline. Results reflect CDRS-R scores collected at the first and second timepoints.

  Baseline and approximately 5 weeks after

• Change in Cognitive Control Capacity - Overall Reaction Time (RT) Stroop

  The Stroop task assesses cognitive control and emotion regulation over emotional information processing by measuring how quickly individuals name the ink color of words that are emotionally-charged or neutral. For this measure, lower scores indicated better performance, i.e., better cognitive control and emotion regulation. Results reflect the average reaction time across all trials of the Stroop task that participants completed.

  Baseline and approximately 5 weeks after

• Change in Cognitive Control Capacity - Conflict RT Stroop

  The Stroop task assesses cognitive control and emotion regulation over emotional information processing by measuring how quickly individuals name the ink color of words that are emotionally-charged or neutral. For this measure, lower scores indicated better performance, i.e., better cognitive control and emotion regulation. Results reflect the difference in the reaction time between incongruent trials and congruent trials on the Stroop task.

  Baseline and approximately 5 weeks after

• Change in Cognitive Control Capacity - Overall RT Flanker

  The Flanker task is a psychological experiment that assesses a person's ability to focus on a target stimulus while ignoring distracting stimuli. For this measure, higher scores indicate better performance. Results reflect the average reaction time across all trials of the Flanker task that participants completed at this timepoint.

  Baseline and approximately 5 weeks after

• Change in Cognitive Control Capacity - Conflict RT Flanker

  The Flanker task is a psychological experiment that assesses a person's ability to focus on a target stimulus while ignoring distracting stimuli. For this measure, higher scores indicate better performance. Results reflect the difference in the reaction time between incongruent trials and congruent trials of the Flanker task.

  Baseline and approximately 5 weeks after

Secondary Outcomes (6)

• Children's Depression Inventory (CDI) at Third Timepoint

  Up to 4 months

• Depressive Symptoms as Measured by Children's Depression Rating Scale - Revised (CDRS-R) at Third Timepoint

  Up to 4 months

• Cognitive Control Capacity - Overall Reaction Time (RT) Stroop

  Up to 4 months

• Cognitive Control Capacity - Conflict RT Stroop

  Up to 4 months

• Cognitive Control Capacity - Overall RT Flanker

  Up to 4 months

Other Outcomes (1)

• Feasibility/Acceptability and Experimental Outcome

  Up to 4 months

Study Arms (1)

Computerized cognitive training (CCT) using EndeavorRx

EXPERIMENTAL

Exciting, youth-friendly computer game, EndeavorRx engages and trains cognitive control across component processes of attention, response inhibition, shifting and working memory.

Device: Computerized cognitive training (CCT) using EndeavorRx

Interventions

Computerized cognitive training (CCT) using EndeavorRx DEVICE

The EndeavorRx video game is a digital therapeutic designed to improve attention and related cognitive control processes by training interference management. \~25 minutes of EndeavorRx video game play per day, for 5 days/week, for up to 4 weeks

Computerized cognitive training (CCT) using EndeavorRx

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Parent or guardian willing to give informed consent, and children willing to give informed assent to participate in the study.
• Males and females (age 9 - 17.99)
• Participant is willing to engage in a technology-based intervention (technology will be provided to participants who live in the state of Michigan, if not already accessible to participant).
• Self-reported depressive symptoms (Children's Depression Inventory \[CDI\] score between 3-19 at Assessment 1)
• Participants will be required to maintain a stable dose of medications

You may not qualify if:

• Color blindness
• Unable to play the video game for any reason
• Current Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) diagnosis of clinical depression, psychosis, or Autism Spectrum Disorder
• Has enrolled in new psychotherapy (for the treatment of a mood or anxiety disorder) or had changes to their psychotherapy in the 4-weeks prior to study enrollment
• Endorses items #1, #2, #3, #4, #5, or #6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Screener (Past-Month); i.e., has present suicidal intention/behavior.
• Has had any changes to their medication in the 4-weeks prior to study enrollment

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Limitations and Caveats

This was a small-scale study, and there was no randomization or control intervention provided.

Results Point of Contact

• Title: Hannah Becker
• Organization: University of Michigan

hcbecker@umich.edu

(734) 764-2580

Study Officials

• Hannah Becker, M.S.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctoral Candidate in Clinical Science

Study Record Dates

• First Submitted: January 7, 2023
• First Posted: January 26, 2023
• Study Start: May 3, 2023
• Primary Completion: July 1, 2024
• Study Completion: August 5, 2024
• Last Updated: June 18, 2025
• Results First Posted: June 18, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)